Nosclav 1000 Amoxicillin and Potassium Clavulanate Tablets

Nosclav-1000 Tablets

(Amoxicillin and Potassium Clavulanate BP)

For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only.



Each film coated tablet contains:

Amoxicillin Trihydrate BP eq. to Amoxicillin 75 mg

Diluted Potassium Clavulanate BP eq. to Clavulanic Acid 125mg

Excipients Q.S.

Colour: Titanium Dioxide BP



Nosclav-1000 is a combination of Amoxicillin and Potassium Clavulanate. The Amoxicillin component of the formulation exerts a bactericidal action against many strains of Gram-positive and Gram-negative organisms. The Clavulanic acid component has little or no antimicrobial action. It does, however, by inactivation of susceptible β-lactamase, protect Amoxicillin from degradation by β-lactamase enzymes produced by penicillin resistant strains of microorganisms.


Antibacterial Activity

Clavulanic acid is an irreversible inhibitor of β-lactamases produced by Staphylococcus aureas, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and Proteus vulgaris, H. influenzae, N. gonorrhoeae and B. fragilis (In vitro activity does not necessarily imply in-vivo efficacy). Potassium clavulanate does not inactivate the chromosamally mediated (Sykes Type 1 Cephalosporinase) β -lactamases produced by Acinetobacter species, Citrobacter species, Enterobacter, indole positive Proteus, Providencia species and Serratia marcencens.



The pharmacokinetics of Amoxicillin and Clavulanic acid are closely allied and neither are adversely affected by the presence of food in the stomach, and are stable in the presence of gastric acid. The oral bioavailability of Amoxicillin and Potassium Clavulante is approximately 90% and 75% respectively.

Peak serum levels of both occur about 1-2 hours after oral administration. Clavulanic acid has about the same plasma elimination half-life (1 hour) as that of Amoxicillin (1.3 hours). Nosclav-1000 is eliminated primarily unchanged through the renal route (glomerular filtration and tubular secretion). Approximately 50- 78% of Amoxicillin and 25-40% of Clavulanic acid are excreted unchanged in urine within the first 6 hours after administration.



Nosclav-1000 is indicated for the treatment of infections caused by Amoxicillin resistant organisms producing β -Iactamases sensitive to Clavulanic acid:

Upper respiratory tract infections: Otitis media, tonsillitis, sinusitis.

Lower respiratory tract infections: Pneumonia, bronchitis (caused by Amoxicillin resistant β -lactamases producing E. coli, H. influenzae and Haemophilus parainfluenzae).

Urinary tract infections: Cystitis, urethritis, pyelonephritis.

Skin and soft tissue infections: Nosclav-1000 formulations will also be effective in the treatment of infections caused by Amoxicillin sensitive organisms at the appropriate Amoxicillin dosage since in this situation the Clavulenic acid component does not contribute to the therapeutic effect.



Allergy to penicillins and cephalosporins.

Safety in pregnancy has not been established.

Nosclav-1000 is contraindicated in patients with a previous history of Amoxicillin and Potassium Clavulanate associated jaundice/hepatic dysfunction. Nosclav-1000 is also contraindicated in infectious mononucleosis. Patients with lymphatic leukemia and patients with hyperuricaemia having been treated with allopurinol may also be at an increased risk of developing skin rashes.



Transient hepatitis and cholestatic jaundice has been reported, hence, Nosclav-1000 should be used with caution in patients with evidence of hepatic dysfunction. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy.

Although anaphylaxis is more frequent following parenteral therapy it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have esperienced severe reactions when treated with cephalosponins. Before initiating therapy with any penicillin, careful inquiry
should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. If an allergic reaction occurs, Nosclav-1000 should be discontinued and the appropriate therapy instituted: adrenaline, corticosteroids, and antihistamines.



Tablets should be taken with meal or as directed by the physician.


Nosclav-1000: 1 Tablet every 12 hours or as directed by the physician.


Dosage In renal failure

Both Amoxicillin and Clavulanic acid are excreted by the kidneys and the serum half-life of each increases in patients with renal failure. Therefore, the dose may need to be reduced or the interval extended.




Sensitivity reactions are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever or urticaria. The hypersensitivity reactions reported are erythernutous maculopapular rashes, urticaria, fever and joint pains. Anaphylactic shock may occur.



Nausea, heartburn, vomiting and diarrhoea.

Pseudomembranous colitis has been reported.



Hepatotoxicity, hepatitis, cholestatic jaundice may occur. A moderate rise in serum glutamic oxalacetic transaminase (SGOT) has been noted, but the significance of this finding is unknown.


Hemic and Lymphatic Systems

Anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia and granulocytopenia have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.


Central Nervous System

Reversible hyperactivity, agitation, anxiety, insomnia, confusion, behavioural changes, and/or dizziness have also been reported. Depression, seizures, or hallucinations.



A sore mouth or tongue and a black hairy tongue have been reported.

Allergic reactions which may include exfoliative dermatitis, other skin rashes, interstitial nephritis and vasculitis, may occur. Erythema multiforme (including Stevens Johnson’s syndrome), toxic episodes of necrolysis.


Clavuanic acid

Gastro-intestinal: Nausea and diarrhea.

Liver: Cholestatic jaundice and hepatitis.



Allergic reactions may occur, usually manifesting as pruritic skin rash, an erythematous skin reaction, urticaria, angiodema, anaphylaxis or eosinophilia. Coomb’s test may become positive. In this event, withdrawal of Nosclav-1000 and the administration of antihistamine will suffice in most cases. Should a serious anaphylactic reaction occur, Nosclav-1000 should be discontinued and the patient treated with the usual agents: adrenaline, corticosteroids and antihistamines.

Treatment with Nosclav-1000 may give rise to a maculopapular rash during therapy or within a few days after completion. The incidence of maculopapular rash is especially high in patients suffering from infectious mononucleosis and hence should be avoided. The use of this antibiotic may lead to the selection of resistant strains of organisms and sensitivity testing should, therefore, be carried out whenever possible, to demonstrate the appropriateness of therapy. Monilial overgrowth such as vaginitis and thrush have been reported.

Treatment with Nosclav-1000 can cause gastrointestinal symptoms such us diarrhoea, nausea and vomiting which can be minimised by administering the medicine at the start of a meal. In addition, as these symptoms are especially related to the Potassium Clavulanate component, where these gastro-intestinal symptoms occur and a higher concentration of Amoxicillin is required, consideration should be given to administering the additional Amoxicillin separately. Caution must be exercised in patients with syphilis as some patients may experience a Jarisch – Herxheimer reaction shortly after starting the treatment. Symptoms include fever, chills, headache and reactions at the site of the lesions. The reactions can be dangerous in cardiovascular syphilis or where there is a serious risk of increased local damage such as optic atrophy. A moderate rise in aspartame tranuaminase/alanine transaminase has been observed in patients treated with this combination.


Impaired renal function

Renal function should be monitored in patients with moderate to severe renal impairment and Nosclav-1000 dosage should be adjusted. High dose should be avoided in patients with impaired renal function/heart failure and in patients receiving potassium sparing diuretics.


Impaired hepatic function

Nosclav-1000 should be used with caution in patients with underlying hepatic disease as hepatic and cholestatic jaundice have been reported with this combination. The condition is more predominant in adult and elderly patients.


Use in lactation

Amoxicillin is excreted in human milk but the excretion of clavulanic acid has not been studied conclusively therefore caution should be exercised when Nosclav-1000 is administered to nursing mothers.



Concurrent use of Nosclav-1000 with probenecid may result in increased and prolonged blood levels of Amoxicillin but since the excretion of Clavulanic acid is unchanged by probenecid, its blood level remains unaffected. Interaction of Nosclav-1000 with coumarin or indandione – derivative anticoagulants, heparin, non-steroidal anti-inflammatory drugs (NSAIDs) especially, aspirin, other platelet aggregation inhibitors or thrombolytic agents may be clinically significant. Nosclav-1000 may decrease the efficacy of oestrogen-containing oral contraceptives.



Nausea, vomiting and diarrhoea may occur with overdosing. Treatment is symptomatic and supportive. Amoxicillin and clavulanic acid may be removed from the circulation by haemodialysis.



Store below 30oC.

Protect from tight and moisture.

Keep out of reach of children.



Nosclav-1000: 2 strips of 7 tablets presented in a carton.


Manufactured in India by

Finecure Pharmaceuticals Ltd.

Shimla Pistaur, Malsa Road, Kichha,

Udham Singh Nagar, Uttarakhand-263148, India.


Marketed by


12 Adewale Crescent, Off Ewenla Street,

Off Oshodi-Apapa Expressway, Oshodi – Lagos,


Ezcef Cefixime USP Tablets


Cefixime Tablets USP 400 mg



Brand Name: EZCEF


Dosage Form And Strenght: Solid Oral Dosage Form; Tablet 400mg

Active Ingredient: Cefixime USP
C16H15N5O7S2.3H2O 6R,7R)-7-{[2-(2-amino-1,3-thiazol-4-yl)-2 (carboxymethoxyimino)acetyl]amino}- 3-ethenyl-8-oxo-5thia azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid.

Net Content: 400mg



Mechanism Of Action

Antimicrobial Spectrum: Cefixime is a semi-synthetic third generation oral cephalosporin with a broad spectrum of antibacterial activity against many Gram positive and Gram negative bacteria. It is highly stable in presence of betalactamases. Cefixime tablet is bactericidal to a wide range of organisms including:

Gram Positive: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae.

Gram Negative: Hemophilus influenzae, Moraxella catarrhalis (Branhamella catarrhalis), Escherichia coli, Proteus vulgaris, Klebsiella species, Pasteurella multocida, Providencia species, Salmonella species, Shigella species, Citrobacter species, Neisseria gonorrheae.

Cefixime is not effective against Pseudomonas spp, group D streptococci (including enterococci), Listeria monolcytogenes, most staphylococcal strains (including methicillin-resistant strains), Enterobacter spp, and most strains of bacteroides and clostridia.


Pharmacokinetics And Metabolism

Absorption: Absorption of cefixime is 40-50% with or without food. The time to maximal absorption is 0.8 hours when Cefixime Tablet is given with food.

Plasma Levels: Peak plasma concentrations (Cmax) are produced 2 to 5 hours (Tmax) with a single dose of Cefixime Tablet Suspension. With doses of 200 to 400 mg, average Cmax is 3 mcg/ml and 4.6 mcg/ml respectively. The Cmax and area under the curve (AUC) are 10-25% with oral suspension as compared to tablets after doses of 100-400 mg of cefixime tablet. Average AUCs are 40% higher at steady state. The plasma half-life of cefixime is 3-4 hours, and may range up to 9 hours.

The serum protein binding is concentration-independent and the bound portion constitutes 65%. It achieves extremely high concentrations in bile following cefixime tablet administration.

Elimination: Approximately 50% of cefixime tablet’s dose is excreted in urine in 24 hours; over 10% of intake is also eliminated via bile.



Cefixime tablet is indicated for the treatment of infections caused by susceptible bacteria for

• Upper respiratory tract infections e.g. Otitis media and other URTI such as pharyngitis and tonsillitis.

• Lower respiratory tract infections e.g. Acute Bronchitis and Acute Exacerbations of Chronic Bronchitis.

• Uncomplicated urinary tract infections e.g. cystitis, cystourethritis, pyelonephritis.



Cefixime contraindicated in patients with known allergy to the cephalosporin group of antibiotics.



Carbamazepine: Elevated carbamazepine levels have been reported in post marketing experience when cefixime is administered concomitantly. Drug monitoring may be of assistance in detecting alterations in carbamazepine plasma concentrations.

Warfarin and Anticoagulants: Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly.



• Periodic assessment of hematopoietic function is advisable during prolonged cefixime tablet therapy.

• Cefixime Tablet is not ideally meant for pregnant lady or lactating mother; however, it could be only if strictly necessary.

• Nursing discontinuation temporarily must be considered whilst taking cefixime tablet. Safety and efficacy of cefixime in children less than 6 months old have not been established.



• Cefixime Tablet should be advocated with caution in presence of renal impairment or GI disease, particularly colitis.

• Prolonged use of cefixime tablet could result in overgrowth of non- susceptible organisms.

• If super infections occur (usually involving Aerobacter, Pseudomonas or Candida spp), cefixime tablet should be discontinued and/or appropriate therapy instituted.



Hypersensitivity: Anaphylactic reaction including shock, internal swelling of the larynx with airways constriction, fever, serum sickness-like reaction, rash, urticaria, angioedema, pruritus and inflammation of mucous membranes. Toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema mutiforme have also rarely been reported.

Haematology: Pancytopenia, leucopenia, eosinophilia, haemolytic anaemia, thrombocytopenia, thrombocytosis, hypereosinophilia, neutropenia, prolongation in prothrombin time and blood coagulation disturbances.
Agranulocytosis has also been rarely reported.

Hepatic: Hepatitis, jaundice, increases in ALT, AST and alkaline phosphatase. Increase in bilirubin.

Gastrointestinal: Serious colitis (such as pseudomembranous colitis), diarrhoea, abdominal pain, vomiting, nausea, dyspepsia, anorexia and flatulence.

Renal: Transient elevation in BUN or creatinine and rare cases of renal failure and interstitial nephritis.

Others: Candidiasis, genital pruritus, vaginitis, headache, dizziness and hyperactivity.



Not Applicable.



There has been limited clinical experiences with overdose of cefixime to date.

Adverse reactions seen at dose levels up to 2g Cefixime in normal subjects did not differ from the profile seen in patients treated at the recommended doses.

Gastric lavage may be indicated in over dosage. No specific antidote exists.

Cefixime is not removed from the circulation in significant quantities by dialysis.



Adults: The recommended dose of cefixime is 400mg daily.

Children 5-10 years: 200mg daily.



Not applicable.



10 x 1 x 10 Tablet Alu Alu Pack.



Store in a dry place at a temperature below 30°C.


Marketed by


19 Ozubulu Street, Fegge Onitsha, Nigeria.


Manufactured by

WEST- COAST Pharmaceutical Works Ltd.

FP No. 17 & 16/5, Meldi Estate, B/s. Meldi Mata Temple, Nr. Gota

Railway Crossing, At & post: Gota, Ahmedabad –382 481, Gujarat. INDIA.

Kefstar Cefuroxime Axetil Tablets USP


Cefuroxime Axetil Tablets USP

For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory.



Each film-coated tablet contains:

Cefuroxime Axetil USP equivalent to anhydrous Cefuroxime 125mg

Each film-coated tablet contains:

Cefuroxime Axetil USP equivalent to anhydrous Cefuroxime 250mg

Each film-coated tablet contains:

Cefuroxime Axetil USP equivalent to anhydrous Cefuroxime 500mg



KEFSTAR (Cefuroxime Axetil) is a semi-synthetic, broad-spectrum cephalosporin antibiotic for oral administration. Cefuroxime is usually bactericidal in action. Its action results from the inhibition of mucopeptide synthesis in the bacterial cell wall.

After oral administration, Cefuroxime Axetil is absorbed from the gastrointestinal tract and rapidly hydrolyzed by nonspecific esterases in the intestinal mucosa and blood to Cefuroxime. Cefuroxime is subsequently distributed throughout the extracellular fluids. The axetil moiety is metabolized to acetaldehyde and acetic acid.



Approximately 50% of serum Cefuroxime is bound to protein.

After a 250mg dose of suspension administered as 2 x 125 mg/5 ml with food in adults, the mean peak serum level is reached in 3 hours and is 2.27mcg/ml. The serum half-life is approximately 1.44 hour and the AUC value is 9.75 mcg -h ml. In children administered a dose of 15 mg/kg, the peak plasma concentration is achieved at 2.7 hours and is 5.1 mcg/ml. The elimination half-life is 1.9g hours and AUC is 22.5 mcg – h ml.

Cefuroxime is excreted unchanged in the urine; in adults approximately 50% of the administered dose is recovered in the urine within 12 hours. The pharmacokinetics of Cefuroxime in the urine of paediatric patients has not been studied at this time. Until further data are available, the renal pharmacokinetic properties of Cefuroxime Axetil established in adults should not be extrapolated to peadiatric patients because Cefuroxime is renally excreted, the serum half-life is prolonged in patients with reduced renal function. Despite the lower elimination of Cefuroxime in geriatric patients, dosage adjustment based on age is not necessary.


Anti-microbial activity

The in vivo bactericidal activity of Cefuroxime Axetil is due to Cefuroxime’s binding to essential target proteins end the resultant inhibition of cell-wall synthesis.

Cefuroxime has bactericidal activity against a wide range of common pathogens, including many beta- lactamase producing strains.

Cefuroxime is stable to many bacterial beta-lactamases, especially plasmid-mediated enzymes that are commonly found in Enterobacteriaceae.


Cefuroxime has been demonstrated to be active against the following microorganisms.

Aerobic gram-positive microorganisms: Staphylococcus aureus (including beta lactamase producing strains), Staphylococcus epidermidis, Staphylococcus

saprophyticus, Staphylococcus agalactiae, Streptococcus pneumoniae and Streptococcus pyogenes.

Aerobic gram-negative microorganisms: Esherichia coli, Haemophilus influenzae (including beta lactamase producing strains), Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis (including beta lactamase producing strains), Neisseria gonorrhoeae (including beta lactamase producing strains), Neisseria meningitidis, Morganella morganii, Proteus incosntans, Proteus mirabilis, Providencia rettgeri, Salmonella spp., Shigella spp.

Spirochetes: Borrelia burgdorferi.


Dosage and Administration

Tablets – The tablets may be given without regard to meals.


Adults and Adolescents (13 years and above)

– Pharyngitis / tonsillitis: 250mg bid for 10 days.

– Acute bacterial exacerbations of chronic bronchitis: 250 or 500 mg bid for 5-10 days.

– Secondary bacterial infections of acute bronchitis: 250 or 500 mg bid for 5-1 0 days.

– Uncomplicated skin and skin structure infections: 250-500 mg bid for 10 days.

– Uncomplicated urinary tract infections: 125 or 250 mg bid for 7 to 10 days.

– Uncomplicated gonorrhoea: 1000mg once as single dose.

– Early Lyme disease: 500mg bid for 20 days.


Pediatric Patients below 13 years (who can swallow tablets whole)

Acute bacterial otitis media: 250mg bid for 10 days.

Acute bacterial maxillary sinusitis :250mg bid for 10 days.



Cefuroxime axetil is a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria:

– Pharyngitis/tonsillitis (adults and pediatric patients).

– Acute bacterial otitis media (pediatric patients).

– Acute bacterial maxillary sinusitis (adults and pediatric patients).

– Acute bacterial exacerbations of chronic bronchitis and secondary bacterial infections of acute bronchitis (adults and pediatric patients 13 years and older).

– Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older).

– Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older).

– Uncomplicated gonorrhea (adults and pediatric patients 13 years and older).

– Early Lyme disease (adults and pediatric patients 13 years and older).

– Impetigo (pediatric patients)



Cefuroxime is contraindicated in patients with a known hypersensitivity (e.g., anaphylaxis) to Cefuroxime or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins).


Warnings and Precautions

Before therapy with Cefuroxime is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs. If this product is to be given to penicillin sensitive patients, caution should be exercised because cross-hypersensitivity among beta-lactam antibiotics has been clearly documented.

Pseudomembranous colitis has been reported with nearly all anti-bacterial agents, including Cefuroxime and may range from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea subsequent to the administration of antibacterial agents.


Drug laboratory test Interactions

A false positive reaction for glucose in the urine may occur with copper reduction tests but not with enzyme based tests for glycosuria. As a false negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase method be used to determine blood/plasma glucose levels in patients receiving Cefuroxime Axetil. The presence of Cefuroxime does not interfere with the assay of serum and urine creatinine by the alkaline picrate method.


Drug/Drug interactions

Oral Contraceptives

Cefuroxime axetil may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives. Counsel patients to consider alternate supplementary (non-hormonal) contraceptive measures during treatment.


Drugs that Reduce Gastric Acidity

Drugs that reduce gastric acidity may result in a lower bioavailability of Cefuroxime compared with administration in the fasting state. Administer Cefuroxime at least 1 hour before or 2 hours after administration of short-acting antacids. Histamine-2 (H2) antagonists and proton pump inhibitors should be avoided.



Concomitant administration of probenecid with Cefuroxime axetil suspension increases serum concentrations of Cefuroxime. Co-administration of probenecid with Cefuroxime axetil is not recommended.


Drug/Laboratory Test Interactions

A false-positive reaction for glucose in the urine may occur with copper reduction tests (e.g., Benedict’s or Fehling’s solution), but not with enzyme-based tests for glycosuria.


Carcinogenesis, Mutagenesis, Impairment of fertility

Although lifetime studies in animals have not been performed to evaluate carcinogenic potential, no mutagenic potential was found for Cefuroxime Axetil.

Reproduction studies in rats at doses up to 1000 mg/kg per day have revealed no evidence of impaired fertility.


Pregnancy and lactation

Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Cefuroxime should be used during pregnancy only if clearly needed.

ecause Cefuroxime is excreted in human milk, caution should be exercised when Cefuroxime is administered to a nursing woman.


Adverse reactions

Cefuroxime is usually well tolerated. The adverse reactions seen are diarrhoea, nausea, and vomiting, transient elevation of SGOT, SGPT and LDH. In <1% of patients, abdominal pain and cramps, flatulence, dyspepsia, headache, vulvar itch, vaginitis, dysuria, chills, swollen tongue, sleepiness, thirst, positive Coomb’s test, muscle stiffness, tightness in chest.

Rarely, haemolytic anemia, Ieukopenia, thrombocytopaenia, jaundice, pseudomembranous colitis, hypersensitivity reactions like anaphylasis angioedema, pruritis, rash and urticaria, seizure, encephalopathy, hepatic impairment including hepatitis and cholestasis, pancytopenia, joint swelling, arthralgia, cough, fever, renal dysfunction, skin reactions like erythema multiforme, Steven Johnsons syndrome and toxic epidermal necrolysis.



Overdosage of cephalosporins can cause cerebral irritation leading to convulsions or encephalopathy. Serum levels of Cefuroxime can be reduced by hemodialysis and peritoneal dialysis.



Store in a cool dry place, protected from light.



125mg, 250mg and 500 mg: Blister of 4 tablets. Blister of 10 tablets.

Kefstar 250mg: NAFDAC Reg. No. 04-8147

Kefstar 500mg: NAFDAC Reg. No. 04-8148


Manufactured by

Sance Laboratories Pvt. Ltd.

VI/51B, P.B. No.2, Kozhuvanal,

Pala, Kottayam – 686573,

Kerala, India.


Manufactured for


Wockhardt Towers, Bandra Kurla Complex,

Mumbai 400051, India